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Caffeine for Sedation Recovery in Children

Phase 1 & 2
Recruiting
Led By Zheng Xie, MD,PhD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age between 3 and 12 years old
Weight less than or equal to 33.3 kg
Must not have
History of Arrhythmia, congenital heart disease, liver, or kidney diseases
Personal or family history of malignant hyperthermia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 hours

Summary

This trial aims to see if caffeine can help children recovering from sedation with Dexmedetomidine after an MRI procedure. Dexmedetomidine is often used for sedation because it has fewer

Who is the study for?
This trial is for pediatric patients who have undergone fast-track surgery and received Dexmedetomidine sedation during an MRI. They must be suitable for receiving caffeine as a potential recovery aid post-MRI.
What is being tested?
The study tests if caffeine can speed up recovery from sedation with Dexmedetomidine in children after an MRI. It measures the time to wake up and meet discharge criteria compared to usual care without caffeine.
What are the potential side effects?
Dexmedetomidine may cause slow heart rate (bradycardia), low blood pressure (hypotension), tiredness, and sluggishness upon waking. Caffeine's side effects are minimal but could include increased heart rate or agitation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 3 and 12 years old.
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My weight is 33.3 kg or less.
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I can get consent from at least one parent.
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My liver and kidneys are functioning well.
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I have no personal or family history of malignant hyperthermia.
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My health is good to moderately impaired.
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I have never had an irregular heartbeat or heart disease from birth.
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I have never had a head injury.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of heart, liver, or kidney diseases.
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I or my family have a history of malignant hyperthermia.
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I cannot give consent myself.
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I weigh more than 33.3 kg.
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I am either younger than 3 years old or older than 12 years old.
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My health is severely impacted by my disease.
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I am currently pregnant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Improve rate of wakefulness post surgery
Secondary study objectives
Time needed to be able to return to tasks performance with purpose

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Dexmedetomidine +/- Caffeine SedationExperimental Treatment1 Intervention
Eligible subjects will be given 10 mg/kg caffeine citrate (equivalent to \~5 mg/ kg caffeine base) \~ 15 min after terminating Dex's infusion.
Group II: Dexmedetomidine +/- Placebo SedationPlacebo Group1 Intervention
Eligible subjects will be given 9 mg/ml saline placebo) \~ 15 min after terminating Dex's infusion.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,056 Previous Clinical Trials
760,809 Total Patients Enrolled
Zheng Xie, MD,PhDPrincipal InvestigatorUniversity of Chicago
~67 spots leftby Jul 2026
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